Status:
TERMINATED
Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)
Lead Sponsor:
Duke University
Collaborating Sponsors:
John Templeton Foundation
Conditions:
Cannabis Use
Drug Use
Eligibility:
All Genders
18-40 years
Brief Summary
The overall objective of this proposed project is to prospectively evaluate the epigenetic and developmental effects of paternal cannabis and other drug use in offspring.
Detailed Description
This project involves enrollment of 40 healthy mother-father dyads that are between the ages of 18 and 40 years. Urine samples for qualitative drug and cotinine testing will be collected from mother-f...
Eligibility Criteria
Inclusion
- Both mother and father are between 18 and 40 years of age
- Free from significant medical conditions, as determined by medical history and examination from attending Obstetrician or health care provider.
- Father is able to be contacted and consents to provide urine and sperm samples
- Both mother and father consent to participation and for the prospective enrollment of their child after birth
- Plan on delivering their baby at one of the two main Duke-affiliated hospitals (Duke University Medical Center and Duke Regional Hospital)
Exclusion
- Mother or Father currently prescribed any psychoactive medication;
- Mother or Father unable to comply with study requirements or otherwise unsuitable for participation in the opinion of the PI.
Key Trial Info
Start Date :
October 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04436055
Start Date
October 26 2020
End Date
July 1 2022
Last Update
March 3 2023
Active Locations (1)
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1
Duke Child and Family Study Center
Durham, North Carolina, United States, 27705